Regulatory Focus™ > News Articles > Veterans Administration Announces Proposal for Drug Development Initiative

Veterans Administration Announces Proposal for Drug Development Initiative

Posted 29 November 2012 | By

The development of pharmaceutical products has typically been the purview of obvious agencies-The National Institutes of Health (NIH), which funds research; the US Food and Drug Administration (FDA), which oversees much of the research and approves products; and the Institute of Medicine (IOM), which provides recommendations about the nation's healthcare system.

Now, you might want to add one more agency to that list: the Department of Veterans Affairs (VA).

The agency, charged with assisting and providing care for the nation's war veterans, is grappling with an influx of war-weary combat veterans returning from combat in Afghanistan and Iraq suffering from post-traumatic stress disorder, better known by its acronym PTSD.

The condition is often caused after experiencing a severe psychological trauma, leaving patients with an overwhelming and debilitating anxiety. Combat veterans, operating for long hours over the course of numerous tours in dangerous situations, are known to be at particular risk for developing the condition.

Treatments for the condition aren't always effective, or at least as effective as the VA would hope-it is often treated using anti-depressants, anti-anxiety medications and sleep aids-but that could soon be changing if the department is successful in a new initiative.

The agency explains that it is interested in forming public-private partnerships under its new Drug Development Initiative (DDI), administered by its Office of Research and Development (ORD), for the purpose of developing new drug treatments to treat PTSD.

"ORD is interested in developing collaborations with organizations that are interested in pursuing clinical trials specifically focused on PTSD," VA wrote in the Federal Register posting on 29 November 2012. "Such research would be detailed through a Cooperative Research and Development Agreement (CRADA) … [which would] delineate the collaboration for PTSD treatment intended to test new drugs to benefit Veterans."

Until now, ORA has primarily been focused on researching the underlying causes of PTSD in the hopes of better being able to treat it, usually using existing therapies. The DDI marks something of a paradigm shift for the agency in that it is now seeking to develop new pharmaceutical therapies to treat the condition.

VA notes its program can support both early- and late-stage clinical trials to test the drug products, and it's looking for companies to send proposals detailing their proposed drug compounds. No proprietary information should be included.

No due date has been set for the initiative, and responses may be sent to Theresa Gleason, senior program manager for clinical science research and development at 

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